NCT06151197已完成3 期
A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis (PFI) (Also Known as Ledderhose Disease)
Endo USA Inc., a Keenova Therapeutics Company136 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2023年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 436
- 试验地点
- 136
- 主要终点
- Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be an ambulatory male or female ≥18 years of age.
- •Have a diagnosis of PFI.
- •Have current foot pain due to PFI.
- •Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
- •If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
- •Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.
排除标准
- •Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
- •Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
- •Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
- •Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
- •Has a clinically significant laboratory abnormality.
- •Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
- •Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- •Is pregnant or plans to become pregnant.
- •Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
EN3835
Experimental
干预措施: EN3835 (Biological)
结局指标
主要结局
Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
时间窗: Baseline, Week 12
次要结局
- Change from Baseline in the FFI Total Score(Baseline, up to Day 85)
- Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score(Baseline, up to Day 85)
- Change from Baseline in the FFI Activity Limitation Subscale Score(Baseline, up to Day 85)
- Change from Baseline in the FFI Pain Subscale Score(Baseline, up to Day 85)
- Number of Participants That Used Rescue Analgesic Medication(Up to Day 85)
- Amount of (milligrams [mg]) Rescue Analgesic Medication Used(Up to Day 85)
- Patient Global Impression of Change (PGIC) Foot Pain Score(Up to Day 85)
- Clinician Global Impression of Change (CGIC) Score(Up to Day 85)
- Subject Satisfaction Score(Up to Day 85)
- Change from Baseline in Nodule Consistency (Firmness)(Baseline, up to Day 85)
- Change from Baseline in the Nodular Hardness of the Treated Nodules(Up to Day 85)
研究者
研究点 (136)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Odevixibat in Patients With Alagille SyndromeAlagille SyndromeNCT04674761Albireo52
终止
3 期
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAHPulmonary Arterial HypertensionNCT02725372Bellerophon Pulse Technologies207
进行中（未招募）
3 期
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's TypeAgitationAlzheimer's Type DementiaNCT05397639Suven Life Sciences Limited375
已完成
2 期
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque PsoriasisPlaque PsoriasisNCT05268016Meiji Pharma USA Inc.132
招募中
3 期
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune ThrombocytopeniaChronic Primary Immune Thrombocytopenia (ITP)NCT06004856Beijing InnoCare Pharma Tech Co., Ltd.195